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Rotator Cuff Injuries clinical trials

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NCT ID: NCT05264922 Withdrawn - Rotator Cuff Tears Clinical Trials

Stromal Vascular Fraction (SVF) Cells for Non-Operative Treatment of Small Rotator Cuff Tears

SVF
Start date: January 9, 2022
Phase: Phase 2
Study type: Interventional

The investigator's goal is to determine the effectiveness of stromal vascular fraction (SVF) cell injection to treat small rotator cuff tears without surgery.

NCT ID: NCT05184985 Withdrawn - Shoulder Pain Clinical Trials

TrueRelief Efficacy for Supraspinatus Tendonitis

Start date: May 4, 2022
Phase: N/A
Study type: Interventional

The investigators hypothesize that TrueRelief will result in improved outcomes for patients with shoulder pain compared to those receiving the sham TrueRelief treatment. Also, it is likely that those with fewer medical comorbidities will experience the greatest improvement.

NCT ID: NCT05082844 Withdrawn - Clinical trials for Cuff Rotator Syndrome

Evaluation of Clinical and Radiographic Outcomes of Surgical Treatment for Rotator Cuff Injury in Patients Over 70

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

The aim of the study is to document the clinical-radiological results from the case series of patients surgically treated for rotator cuff lesions from 2009 to 2020 at the Rizzoli Orthopaedic Institute Shoulder-Elbow Department.

NCT ID: NCT04705376 Withdrawn - Rotator Cuff Tears Clinical Trials

Cryotherapy Following Rotator Cuff Repair Surgery

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

The purpose of this prospective crossover study is to determine if noninferiority exists in the use of the Thermazone cryotherapy machine when compared to Breg Polarcare, the current standard-of-care cryotherapy machine, for control of pain and reduction in postoperative narcotic medication consumption following arthroscopic rotator cuff repair surgery. Specifically, the investigators propose to test the hypothesis that in adults having arthroscopic rotator cuff repairs, the Thermazone device is non-inferior to Breg Polarcare on postoperative pain and opioid use over the initial 8 postoperative days.

NCT ID: NCT04461028 Withdrawn - Rotator Cuff Tears Clinical Trials

Liposomal Bupivacaine in Shoulder Arthroscopy

Start date: February 21, 2019
Phase: Phase 3
Study type: Interventional

Background: The research study is being conducted to see if using the liposomal Bupivacaine for the Interscalene block will improve the patient pain control and the whole patient's experience 48 hours after surgery when compared to using the regular Marcaine (bupivacaine hydrochloride) in addition to the dexamethasone. All preoperative, surgical, post-operative care in the recovery room, and discharge instructions will be the same as any other patient undergoing this surgery. Study procedures: 1. After obtaining informed consent, an anesthesiologist will receive an envelope with result of randomization. Patients will receive a single injection interscalene nerve block prior to surgery 2. Patients will be randomized to one of two groups: - GROUP 1 liposomal Bupivacaine - will receive a 20 ml mixture of 10 ml of Liposomal Bupivacaine 1.3% and 10 ml of Bupivacaine HCl 0.5%. - GROUP 2 Bupivacaine with dexamethasone - will receive 20 ml of Bupivacaine HCl 0.5% with 4 mg of preservative-free dexamethasone. 4. Patients will undergo general endotracheal anesthesia with inhaled anesthetic (Sevoflurane) for a goal MAC 1.0. Other than the aforementioned interscalene nerve block, patients will not receive any other local anesthetic. 5. Patients will receive a multimodal analgesic and antiemetic regimen standardized for shoulder arthroscopies at our institution. Preoperatively, all patients will receive 300 mg of gabapentin and 1,000 mg of acetaminophen orally. Intraoperatively, patients will receive 4 mg of ondansetron and 15 mg of ketorolac intravenously. Postoperatively, patients will remain on an oral regimen of 300 mg of gabapentin three times daily for one week, and 1,000 mg of acetaminophen and 10 mg of ketorolac every 8 hours for 48 hours after surgery. 6. Additional intraoperative or postoperative opioid analgesics will be administered as needed. Patients with a history of PONV or otherwise deemed high risk for PONV by the attending anesthesiologist will receive a scopolamine patch before induction of general anesthesia.

NCT ID: NCT04361266 Withdrawn - Rotator Cuff Tears Clinical Trials

Use of Nanoscaffold Augmentation in Rotator Cuff Repair: Clinical Outcome and Ultrasound Assessment of Healing Rates and Vascularity

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

The purpose is to assess Rotium, a novel nanoscaffold, impact on healing of a repaired rotator cuff and compare to a repair without Rotium. Animal (sheep) models have shown both quicker and more organized healing when Rotium is used, but there are no studies to confirm these outcomes translate to human population. Hypothesis: Rotium rotator cuff repairs will heal both quicker and better than traditional rotator cuff repair techniques.

NCT ID: NCT04345666 Withdrawn - Rotator Cuff Tears Clinical Trials

Can Testosterone Accelerate Injury Recovery After Arthroscopic Rotator Cuff Repair

Start date: August 2021
Phase: Phase 2/Phase 3
Study type: Interventional

The objective of this study is to determine if treating patients undergoing arthroscopic rotator cuff repair with testosterone will allow patients to accelerate their recovery time after surgery.

NCT ID: NCT04285606 Withdrawn - Clinical trials for Shoulder Osteoarthritis

Effect of Postop Rehab Methods on Outcomes Following Reverse Shoulder Arthroplasty

Start date: July 8, 2020
Phase: N/A
Study type: Interventional

Notwithstanding the rapid increase in utilization of reverse total shoulder arthroplasty (RTSA), little consensus or high-quality evidence exists regarding optimal rehab methods following the procedure. Our research question is how different rehab methods influence the clinical outcomes following RTSA. This proposal presents a prospective randomized clinical trial where 100 eligible RTSA patients will be randomly assigned to two rehab groups (Short immobilization with patient-directed therapy vs Long immobilization with supervised therapy) at a single institution. Patient-reported outcomes, objective clinical data, and complications will be compared between the groups over a period of 2 years.

NCT ID: NCT04062838 Withdrawn - Rotator Cuff Tear Clinical Trials

Prolotherapy for the Treatment of Partial Rotator Cuff Tears

Start date: August 1, 2020
Phase: Phase 4
Study type: Interventional

This is a Prospective Pilot Single Arm study on prolotherapy for the treatment of patients with pain due to Partial Rotator Cuff (RC) Tears of the Shoulder. The aim of this trial is to study the effects of injected glucose on injured or degenerative RC tears of the shoulder. Glucose is not recognized by the FDA for this purpose but is used in 2 main concentrations: 50% solution to treat hypoglycemia and 5% solution for fluid replacement. In the prolotherapy group, 20% dextrose will be injected into 4 locations of the affected shoulder. In the active control group, patients will receive a single injection of methylprednisolone into the subacromial bursa and 3 saline injections overlying the tendons.

NCT ID: NCT04027205 Withdrawn - Clinical trials for Traumatic Rotator Cuff Tear

Surgery Versus PhysiothErapist-leD Exercise for Traumatic Tears of the Rotator Cuff

SPeEDy
Start date: March 3, 2020
Phase: N/A
Study type: Interventional

The SPeEDy study is a parallel group, pilot and feasibility randomised controlled trial (RCT) with integrated Quintet Recruitment Intervention (QRI) and further qualitative interviews. The study hypothesis is: In adult patients diagnosed with traumatic tears of the rotator cuff, is it feasible to conduct a future, substantive, multi-site RCT to test the hypothesis that physiotherapist-led exercise is not inferior to surgical repair of the rotator cuff in terms of clinical outcomes but is more cost-effective.